FDA.reportPublic FDA data

SemiCut Coax.

Primary DI
08058341217313
Brand
SemiCut Coax.
Company
M.D.L. S.R.L.
Model
PD0PP1407
Catalog number
PD0PP1407
Device description
DISPOSABLE SEMIAUTOMATIC GUILLOTINE NEEDLE 14G X 70 mm FOR SOFT TISSUE BIOPSY WITHOUT REMOVABLE LUER, WITH INTRODUCER
Published
2021-04-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FCGBiopsy Needle
KNWInstrument, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCGBiopsy NeedleGastroenterology, Urology2
KNWInstrument, BiopsyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160316000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160316000SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer NeedlesM.D.L. S.R.L.2016-10-27KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08058341217313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058341217313080583412173138058341217313

GMDN Terms#

Term, Definition table
TermDefinition
End-cut biopsy gun handpiece/needleA hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a core tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, open, cylindrical biopsy needle that allows a full-width tissue sample to be obtained over the entire length of the biopsy when activated. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
447228586
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08032986359416AutoMarkPNA2005PNA20052017-01-05
08032986359447AutoMarkPNAX2005PNAX20052017-01-05
08032986359867RepoMarkPR2005PR20052017-01-05
08052440107407MarkPNX2007PNX20072017-06-05
08052440107445MarkPNX2010PNX20102017-02-21
08052440107469MarkPN2012PN20122017-03-23
08052440107759AutoMarkPNAX2010PNAX20102017-06-05
08052440107841RepoMarkPR2007PR20072017-01-05
08052440107858RepoMarkPR2010PR20102017-06-05
08056138586222MarkPN2010PN20102021-05-14
08056138586239MarkPN2012PN20122021-05-14
08056138586246MarkPN2015PN20152021-05-17
08056138586253AutoMarkPNA2005PNA20052021-05-17
08056138586260AutoMarkPNA2010PNA20102021-05-17
08056138586277AutoMarkPNA2015PNA20152021-05-17
08056138586307MarkSlimPNS2010PNS20102021-05-17
08056138586314MarkslimPNS2015PNS20152021-05-17
08056138586369RepoMarkPR2007PR20072021-05-17
08056138586376RepoMarkPR2010PR20102021-05-17
08056138586383RepoMarkPR2015PR20152021-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00817295021081InradInradKNW2026-10-08
00817295021081InradInradFCG2026-10-08
00817295021098InradInradKNW2026-10-08
00817295021098InradInradFCG2026-10-08
00817295021104InradInradKNW2026-10-08
00817295021104InradInradFCG2026-10-08
00817295021111InradInradKNW2026-10-08
00817295021111InradInradFCG2026-10-08
00817295021128InradInradKNW2026-10-08
00817295021128InradInradFCG2026-10-08
00817295021135InradInradFCG2026-10-08
00817295021135InradInradKNW2026-10-08
00817295021142InradInradFCG2026-10-08
00817295021142InradInradKNW2026-10-08
00817295021159InradInradFCG2026-10-08
00817295021159InradInradKNW2026-10-08
00817295021357InradInradKNW2026-10-08
00817295021357InradInradFCG2026-10-08
00817295021364InradInradFCG2026-10-08
00817295021364InradInradKNW2026-10-08
00817295021371InradInradKNW2026-10-08
00817295021371InradInradFCG2026-10-08
00817295021388InradInradFCG2026-10-08
00817295021388InradInradKNW2026-10-08
08055002906272COXMEDAX SRL UNIPERSONALEKNW2026-10-07
10884521833098SharkCoreCovidien LPFCG2026-10-01
10884450831547Tru-Cut®Merit Medical Systems, Inc.KNW2026-09-29
00888867543904Arthrex®ARTHREX, INC.KNW2026-09-25